Glossary
Also written clinical need; clinical difference
Where an approved product exists, section 503A does not permit a pharmacy to compound what is essentially a copy of it. The exception is a documented clinical difference for an individual patient: a prescriber must record a clinical need that the approved product cannot meet.
The standard is narrower than the market reads it. The FDA has rejected price as such a difference, which is the substance of what changed for compounded semaglutide and tirzepatide once the shortages resolved; affordability is a real problem and it is not a clinical need within the meaning of the provision.